1. Cardiologists Role in EVAR with the Development of Low Profile Devices
J. Michael Bacharach MD MPH FACC
Clinical Professor of Medicine University of South Dakota
Section Head Vascular Medicine, North Central Heart Institute Sioux Falls South Dakota
Associate Professor of Surgery Mayo Clinic Graduate School of Medicine

2. I have no real or apparent conflicts of interest to report.
J. Michael Bacharach, MD, MPH
I have no real or apparent conflicts of interest to report.

4. Dinosaurs Once Ruled The Earth
Dinosaurs once ruled the earth. They were bigger, stronger and more powerful then other living creatures ……. But they failed to adapt.

5. Tradition – defined as….
The handing down of beliefs or customs from one generation to another, especially without writing
A belief or custom handed down in this way, a long established custom or method of procedure

6. Tradition
For years the tradition was that surgeons cared for patients with abdominal aortic aneurysms
Once identified these patients were followed by surgeons
When aneurysms became large enough or symptomatic, they were treated with surgical aneurysmectomy

7. 2/26/1951 Freeman&Leeds (Vein inlay graft)
3/2/1951 Schafer&Hardin (Homograft)
3/13/1953 Bahnson st repair ruptured AAA
1954 Cooley Dacron graft refined
9/6/1990 Parodi Endo tube graft
2012: 15 Endovascular devices (5 FDA approved) (2) 14 F devices in Trials
Friedman SG. JVS 2001;33: Yao JST. CV Surg 2003;11:413-5

8. Evolution
As with most things in the world, the influences of evolution require adaptation to survive
Endografts represent an evolution in technology that has resulted in a less invasive method of treating aneurysmal disease

9. Procedure volume for OSR (surg repair) of AAAs compared with EVAR in the Medicare fee-for- service population, 2001 to 2006.
J Am Coll Radiol 2009;6:

10. Current Utilization of EVAR by Specialty
The combined utilization rate per 100,000 of the two types of interventions for AAA (EVAR and OSR) decreased from 121 in 2001 to 119 in In performing EVAR, procedure volume and market share in 2006 by specialty were
1) 22,003 procedures by surgeons, a 76% share;
2) 3,287 procedures by radiologists, an 11% share;
3) 1,915 procedures by cardiologists, a 7% share; and
4) 1,732 procedures by all other physicians, a 6% share.
J Am Coll Radiol 2009;6:

11. Adaptation This change in technology has required a new set of skills
Imaging and the recognition that certain aortic morphology is well suited for EVAR and recognizing those who are not
Catheter based skills
No longer is cutting and suturing required
Rather manipulation of small catheters and wires under fluoroscopic guidance and without the aid of direct tactile manipulation

12. Elements of Management of the Patient With AAA
Recognize and diagnose aneurysmal disease
Apply appropriate imaging to risk stratify and determine need for intervention
Risk factor management and management of co-morbidities
Intervention
On-going care and surveillance

13. Components of Treating Patients with Aneurysmal Disease
Recognition….clearly a physician trained to care for patients can through history, examination and adjunctive imaging identify aneurysmal disease
Imaging….requires familiarity with both advances and limitations of modern imaging, and the ability to convert the imaging into data that can be translated into determining the suitability of a patient for endovascular treatment

14. Components of Treating Patients with Aneurysmal Disease
Judgement and experience….knowing when to say “NO”
Catheter-based skills….needed for procedural success, familiarity with device characteristics and the ability to adapt the best device to achieve the best outcome
Surveillance….commitment to continue to follow and care for the patient after the procedure

15. Patient Selection
Not all aneurysmal disease is suited for endovascular therapy
There continues to be aneurysms that do not lend themselves to this type of treatment and still require skilled surgeons to perform open repair

16. Contribution to the Technology
While surgeons have contributed significantly in the development of endovascular aneurysm therapy, it would be disingenuous not to recognize the significant contribution made by cardiologists and radiologists in the development of EVAR into an effective therapy that has significantly reduced the morbidity and mortality associated with traditional surgical treatment.

17. Development
Mature Technology
Development
Innovation

18. Percutaneous Endograft Placement
1999

20. Contained Rupture Rx’ed EVAR

21. Fenestrated Cook Zenith Graft

22. Ovation™ Abdominal Stent Graft System
Tri-Modular Design
Suprarenal Stent with Anchors for Fixation
14F OD
PTFE Main Body
Polymer Filled Rings for Optimal Seal
Low-Viscosity Radiopaque Fill
Polymer
13F OD
Iliac Limbs
Sealing Rings Conform to Anatomy

23. Procedure Characteristics
PROCEDURE DATA
Total Procedure Time (mins)
avg +/- (SD)
109.9, (41.4)
Device Time (mins)
44.1, (18.9)
Procedural Blood Loss (cc)
229.5, (263.9)
ANESTHESIA*
General Anesthesia
65.8%
106/161
Regional Anesthesia
16.8%
27/161
Local or Conscious Sedation
34.8%
56/161
PRIMARY VESSEL ACCESS
Percutaneous
46.6%
Cut Down
53.4%
* Some patients received more than one type of anesthesia.

24. The Concept that EVAR is So Complicated
That Non-surgeons Cannot do it is Laughable !
But……. It does require adequate commitment and training

25. These necessary components are not unique to surgeons, but with adequate and appropriate training, can be achieved by cardiologists, vascular medicine specialists and interventional radiologists.

26. Challenges Catheter skills are not enough !
How to change existing training programs to cultivate the necessary cognitive and procedural skill to perform EVAR
It is clearly an advanced level skill and commitment that is required

27. Rogers' 5 Factors Rogers defines several intrinsic characteristics of innovations that influence an individual’s decision to adopt or reject an innovation.
Factor Definition
Relative Advantage How improved an innovation is over the previous generation.
Compatibility The level of compatibility that an innovation has to be assimilated into an individual’s life.
Complexity or
Simplicity If the innovation is too difficult to use an individual will not likely adopt it.
Trialability How easily an innovation may be experimented with as it is being adopted. I a user has a hard time using and trying an innovation this individual will be less likely to adopt it.
Observability The extent that an innovation is visible to others. An innovation that is more visible will drive communication among the individual’s peers and personal networks and will in turn create more positive or negative reactions.

28. File:Diffusionofideas
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[edit]SummaryDescription The diffusion of innovations according to Rogers (1962). With successive groups of consumers adopting the new technology (shown in blue), its market share (yellow) will eventually reach the saturation level.
Date
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Innovation Curve

29. Adopter category Definition
Innovators
Innovators are the first individuals to adopt an innovation. Innovators are willing to take risks, youngest in age, have the higher social class, have great financial lucidity, very social and have closest contact to scientific sources and interaction with other innovators. Risk tolerance has them adopting technologies which may ultimately fail. Financial resources help absorb these failures. (Rogers th ed, p. 282)
Early Adopters
This is the second fastest category of individuals who adopt an innovation. These individuals have the highest degree of opinion leadership among the other adopter categories. Early adopters are typically younger in age, have a higher social status, have more financial lucidity, advanced education, and are more socially forward than late adopters. More discrete in adoption choices than innovators. Realize judicious choice of adoption will help them maintain central communication position (Rogers th ed, p. 283).
Early Majority
Individuals in this category adopt an innovation after a varying degree of time. This time of adoption is significantly longer than the innovators and early adopters. Early Majority tend to be slower in the adoption process, have above average social status, contact with early adopters, and seldom hold positions of opinion leadership in a system (Rogers th ed, p. 283)
Late Majority
Individuals in this category will adopt an innovation after the average member of the society. These individuals approach an innovation with a high degree of skepticism and after the majority of society has adopted the innovation. Late Majority are typically skeptical about an innovation, have below average social status, very little financial lucidity, in contact with others in late majority and early majority, very little opinion leadership.
Laggards
Individuals in this category are the last to adopt an innovation. Unlike some of the previous categories, individuals in this category show little to no opinion leadership. These individuals typically have an aversion to change-agents and tend to be advanced in age. Laggards typically tend to be focused on “traditions”, likely to have lowest social status, lowest financial fluidity, be oldest of all other adopters, in contact with only family and close friends, very little to no opinion leadership.

30. The Future?

31. Summary
EVAR has replaced open surgical repair for the majority of AAA pts with suitable anatomy
Evolution of technology has improved results, extended applications, and in many cases no longer requires surgical based access
Cardiologists have superb catheter skills that are well suited for EVAR
Existing training programs need to change to cultivate the required cognitive and procedural skills